Stents are tubular scaffold structures used to prop open blood vessels and other body lumens. The most widespread use of stents is to open clogged coronary arteries and prevent restenosis. The use of stents coated with therapeutic agents has been proposed to help minimize the possibility of restenosis. For example, stents coated with paclitaxel have been shown to reduce restenosis rates when compared with uncoated stents.
Although a number of drug coated stents have been reported, there has been a lack of published information regarding the optimization of drug dosing and drug release kinetics to address safety and efficacy. There is thus a need to identify, for a given coated stent system, the effective therapeutic window based on the selection of an appropriate drug dose to obtain a desired biological response.